PMS Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine twice daily, with or without food. The total daily dose for the first 4 days is 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. From day 4 onward, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. As monotherapy or as adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg on day 4. The total daily dose may be increased to 800 mg by day 6, in increments of no more than 200mg per day. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose for the first 4 days should reach 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In confirmatory clinical trials of this medicine, doses of 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, 400 mg on day 5, and up to 600 mg on day 8 were administered. The recommended daily dose is 300 mg. Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials have shown that the dose may be reduced to a minimum of 200 mg. (3) Prevention of recurrence of bipolar disorder: Adults: To prevent recurrence of manic, mixed, or depressive episodes associated with bipolar disorder, patients who responded to quetiapine for acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start treatment with 25 mg/day and have the dose gradually increased by 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment: Following oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start treatment with 25 mg/day and have the dose gradually increased by 25～50 mg per day until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

This medication is primarily prescribed for the treatment of psychiatric disorders, particularly depression, schizophrenia, and bipolar disorder. There is an increased risk of suicidal thoughts, especially in young patients between the ages of 18 and 24, who should be closely monitored while taking this medication. Blood sugar levels may rise, so diabetic patients or those at risk of diabetes should regularly check their blood sugar and carefully observe for symptoms of high blood sugar, such as thirst, frequent urination, and fatigue. Rarely, Neuroleptic Malignant Syndrome can occur, characterized by severe muscle rigidity, high fever, and altered consciousness; these symptoms require immediate consultation with a healthcare professional. Long-term use may lead to tardive dyskinesia, involuntary movements around the face, mouth, hands, and feet; if symptoms appear, consult a physician. Using this medication in elderly patients with dementia may increase the risk of death, and it is advised not to use this medication in such cases. There is a rare chance of developing agranulocytosis or severe neutropenia, which can cause a sudden decrease in white blood cell count, so inform healthcare professionals immediately if fever or symptoms of infection occur. Patients at risk of stroke or with cardiovascular issues should exercise caution when using this medication. Be aware of the risk of thrombosis; if symptoms such as leg pain, swelling, or shortness of breath occur, consult a doctor immediately. Patients with impaired liver function may experience increased drug concentration; start with a low dose and monitor carefully. This medication may cause drowsiness and dizziness, so it is advisable to avoid driving or operating dangerous machinery. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, especially in the last three months of pregnancy, as withdrawal symptoms may occur in newborns. Abrupt discontinuation can lead to withdrawal symptoms or worsening of symptoms; dosage should be gradually reduced when discontinuing. This medication may have heightened side effects when taken with other central nervous system depressants or alcohol. Furthermore, when used in conjunction with drugs that inhibit or induce specific liver metabolic enzymes, this medication's effects may be altered; inform your doctor of any other medications being taken. If severe skin rashes, fever, swollen lymph nodes, or other symptoms occur during treatment, stop taking the medication and seek medical advice immediately. The safety and efficacy of this medication have not been established in children and adolescents, so it is generally not used in this population. In case of overdose, symptoms such as drowsiness, hypotension, and heart rate changes may occur, requiring immediate emergency treatment. Lastly, this medication should be kept out of reach of children, and it is safe not to transfer it to other containers.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication should be stored in a closed container, as it may be sensitive to air or moisture. It is also important to store the medication in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle